New e-mail Address.

With the demise of our old Internet Service Provider (Pipex) we reluctantly have to break our twenty year tie with them.  The shop e-mail remains as was.

alex.kennedy@validation-online.net

 

However the direct contact e-mail for my attention was:-

alex.kennedy@dsl.pipex.com

 

This is now changed to:-

alex.kennedy@validation-online.com

 

Please amend any records you have accordingly

Combination IQ/OQ/PQ Protocol.

Combination IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several hundred reader suggestions we received in our - Suggestions Section. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment. It is an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to facilitate ease of final editing by the end user. It has become a very popular document.

Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
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Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00
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Software Validation SOP (Issue-2) -- $22.00

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Software Validation Master Plan (issue-2) -- $115.00
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Software Validation Risk Assessment (Issue 2) -- $125.00
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Software User Requirements Specification. (Issue 2) -- $115.00
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Software Validation Plan (Issue 2) -- $89.00
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Software Design Qualification. (Issue 2) -- $89.00
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Software Installation Qualification. (Issue 2) -- $89.00

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Software Operational Qualification. (Issue 2) -- $89.00
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Software Performance Qualification. (Issue 2) -- $89.00
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Software Validation Package (Issue 1) -- $699.00
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Validation Risk Assessment (Issue10.) -- $125.00

This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.


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Combined IQ / OQ Protocol.
New from Validation Online a Combined almost ready to use; IQ-OQ protocol. Designed to cover equipment in general and specifically laboratory type equipment, with or without embedded or programmable software. This is not a list of chapter headings. It is a fully detailed interactive IQ and OQ protocol.


Combined_IQ-OQ_Issue-1 -- $125.00
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Are you ready for an inspection?

With HEPA filters, the manufacturers recommended dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download.  Regulators ask to review your writen justification for these filter change PD's; make certain you have them.

Purchase your copy of this test script now at Special Price of $22.00.
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Free Validation Document Downloads

Click Here for further details of CAPA AUDIT document.

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